Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-28 @ 2:57 AM
Study NCT ID:
NCT03754257
Status:
COMPLETED
Last Update Posted:
2024-10-29
First Post:
2018-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Electrical Stimulation for Preventing Loss of Muscle Mass in Patients With SIRS, Sepsis and Septic Shock
Sponsor:
Hospital Sirio-Libanes
Organization:
Study Overview
Official Title:
Effects of Electrical Stimulation for Preventing Loss of Muscle Mass in Patients With SIRS, Sepsis and Septic Shock - Randomized, Controlled and Double-blind Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background: Electrical stimulation has been used in critical patients as an adjunct strategy of early rehabilitation. In septic or septic shock patients there are reports of only two studies in the literature, with conflicting results.
Objective: To evaluate the effects of electrical stimulation in the prevention of muscle mass loss in patients admitted to the ICU with systemic inflammatory response syndrome (SIRS), sepsis or septic shock.
Methods: This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a diagnosis of SIRS, sepsis or septic shock (including patients with sepsis due to the new coronavirus - COVID-19) will be randomly assigned to experimental group and sham group. They will be evaluated in relation to muscle mass, peripheral muscle strength and functional status. They will also be submitted to the collection of inflammatory, metabolic, damage and muscular trophism markers.
Expected results: Electrical stimulation is expected to be able to prevent loss of muscle mass in patients admitted to the ICU with SIRS, sepsis or septic shock. In addition, it is expected to be able to preserve strength in this population without increasing the pro-inflammatory or metabolic response.
Objective: To evaluate the effects of electrical stimulation in the prevention of muscle mass loss in patients admitted to the ICU with systemic inflammatory response syndrome (SIRS), sepsis or septic shock.
Methods: This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a diagnosis of SIRS, sepsis or septic shock (including patients with sepsis due to the new coronavirus - COVID-19) will be randomly assigned to experimental group and sham group. They will be evaluated in relation to muscle mass, peripheral muscle strength and functional status. They will also be submitted to the collection of inflammatory, metabolic, damage and muscular trophism markers.
Expected results: Electrical stimulation is expected to be able to prevent loss of muscle mass in patients admitted to the ICU with SIRS, sepsis or septic shock. In addition, it is expected to be able to preserve strength in this population without increasing the pro-inflammatory or metabolic response.
Detailed Description:
This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a diagnosis of SIRS, sepsis or septic shock (including patients with sepsis due to the new coronavirus - COVID-19) will be randomly assigned to experimental group and sham group.They will be evaluated in relation to muscle mass, peripheral muscle strength and functional status. They will also be submitted to the collection of inflammatory, metabolic, damage and muscular trophism markers.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: